MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II ILIAC STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	ETLW1624C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	11/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: e tbf3216c124e, serial/lot #: (b)(4), ubd: 03-jun-2016, udi #: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 90 mm diameter abdominal aortic aneurysm.It was reported that the patient presented for follow up approximately 5 years post index procedure with abdominal pain.An enlarged aaa sac was observed on the cta, which the physician believed to be due to a type iiia separation leak between the bottom of the main body limb and the endurant ii limb extension.The patient was treated with implant of an additional limb to bridge the type iiia endoleak.The event was then resolved.As per the physician, the cause of the event was related to the patient's anatomy.It was noted that there was large aaa sac with no thrombus, and that the physician believed that the patient's disease was progressing in the neck and iliac's of the aorta.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film analysis summary; the reported component detachment between the bifurcate ipsi limb and the right limb extension, with a resulting type iiia endoleak and aaa expansion was confirmed; however, the exact cause could not be determined from the films provided.The anatomy at implant is unknown, the amount of component overlap at implant could not be determined, and earlier post-implant ct¿s were not available for comparison.There was severe angulation observed between the infrarenal neck and iliac limbs, and it is therefore possible that aneurysm morphology changes contributed to the limb detachment.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9395338
• Report Number: 9612164-2019-04970
• Device Sequence Number: 2708732
• Product Code: MIH
• UDI-Device Identifier: 00613994991690
• UDI-Public: 00613994991690
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2016
• Device Model Number: ETLW1624C124E
• Device Catalogue Number: ETLW1624C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 84